G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00770172|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : May 13, 2011
RATIONALE: Colony-stimulating factors, such as G-CSF, may increase the number of white blood cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in patients receiving chemotherapy. It is not yet known which regimen of G-CSF may be more effective in preventing neutropenia.
PURPOSE: This randomized phase III trial is comparing two different regimens of G-CSF to see how well it works in preventing persistent neutropenia in patients with solid tumors who are receiving chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapeutic Agent Toxicity Neutropenia Unspecified Adult Solid Tumor, Protocol Specific||Biological: filgrastim||Phase 3|
- Determine the efficacy of filgrastim (G-CSF) in preventing persistent moderate neutropenia in patients with solid tumors while maintaining chemotherapy courses.
- Compare the tolerability of 2 regimens of G-CSF in these patients.
- Determine the number of courses of G-CSF needed in each regimen.
- Evaluate the frequency of infections.
- Determine dose intensity.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 6 days beginning 1 week after the start of chemotherapy (days 7-12). If chemotherapy begins on day 8, patients receive G-CSF SC on days 9-14.
- Arm II: Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Moderate Persistent Neutropenia: Comparison of Administration of G-CSF (Granulocyte Colony Stimulating Factor) 1 Day Out of 2 Versus Traditional Schedules to Maintain Dose Intensity. Phase III Multicenter Study in Patients With Solid Tumors Receiving Chemotherapy|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||May 2011|
U.S. FDA Resources
Experimental: Arm I
Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 6 days beginning 1 week after the start of chemotherapy (days 7-12). If chemotherapy begins on day 8, patients receive G-CSF SC on days 9-14.
Experimental: Arm II
Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.
- Number of courses of G-CSF required
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770172
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Study Chair:||Florence Joly, MD, PhD||Centre Francois Baclesse|